FDA.reportPublic FDA data

510(k) K230765

Device
Precice Ankle Salvage System
Applicant
Nuvasive Specialized Orthopedics, Inc.
510(k) number
K230765
Product code
HSB
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-29
Date received
2023-03-20
Regulation
888.3020
Classification name
Rod, Fixation, Intramedullary And Accessories
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Miriam Cervantes
Address
101 Enterprise, Suite 100 Alisa Viejo CA US 92656 92656

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HSB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261481Pangea Femur Reconstruction SystemStryker GmbH2026-06-29
K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.2026-06-18
K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics2026-06-18
K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.2026-06-17
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K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.2026-04-24
K252016Arthrex Humeral NailsArthrex, Inc.2026-03-20
K252961Fusion FibFix NailFusion Orthopedics USA, LLC2026-03-18
K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.2026-03-12
K253517Reselute Tibial NailReselute, Inc.2026-03-10
K252196Arthrex FibuLock Nail SystemArthrex, Inc.2026-03-05
K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.2026-03-05
K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.2026-03-04